Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

Refractive Error Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01718184
• Other study ID #: RabinMC Sulcoflex Toric IOL
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2012
• Last updated: October 29, 2012
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: July 2012
• Source: Rabin Medical Center
• Contact: Irit Bahar, MD
• Phone: 972-3-9376101
• Email: iritbahar[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Rabin Medical Center
• Study type: Interventional

Clinical Trial Summary

A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric intraocular lens in pseudophakic patients for correcting refractive errors following corneal transplantation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• after corneal transplantation with refractive errors

• after cataract removal and intraocular lens implantation

Exclusion Criteria:

• other ophthalmologic disorders limiting vision including glaucoma, AMD, profound amblyopia

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Implantation
• Intraocular Lens Implantation
• Refractive Error
• Refractive Errors

Intervention

Procedure:
• toric intraocular lens implantation
piggyback Sulcolflex toric intraocular lens implantation
• Sulcoflex intraocular lens implantation

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tiqwa

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Einat Medical Inc.

Country where clinical trial is conducted

Israel, 

References & Publications (17)

Baumeister M, Kohnen T. Scheimpflug measurement of intraocular lens position after piggyback implantation of foldable intraocular lenses in eyes with high hyperopia. J Cataract Refract Surg. 2006 Dec;32(12):2098-104. — View Citation

Chang SH, Lim G. Secondary pigmentary glaucoma associated with piggyback intraocular lens implantation. J Cataract Refract Surg. 2004 Oct;30(10):2219-22. — View Citation

Chang WH, Werner L, Fry LL, Johnson JT, Kamae K, Mamalis N. Pigmentary dispersion syndrome with a secondary piggyback 3-piece hydrophobic acrylic lens. Case report with clinicopathological correlation. J Cataract Refract Surg. 2007 Jun;33(6):1106-9. — View Citation

Durak I, Ferliel ST, Söylev M, Saatçi O. Pre-Descemet's membrane hemorrhage after secondary intraocular lens implantation. J Cataract Refract Surg. 1999 Nov;25(11):1554-6. — View Citation

Gayton JL, Sanders V, Van der Karr M, Raanan MG. Piggybacking intraocular implants to correct pseudophakic refractive error. Ophthalmology. 1999 Jan;106(1):56-9. — View Citation

Gayton JL, Sanders VN. Implanting two posterior chamber intraocular lenses in a case of microphthalmos. J Cataract Refract Surg. 1993 Nov;19(6):776-7. — View Citation

Gayton JL. Secondary implantation of a double intraocular lens after penetrating keratoplasty. J Cataract Refract Surg. 1998 Feb;24(2):281-2. — View Citation

Habot-Wilner Z, Sachs D, Cahane M, Alhalel A, Desatnik H, Schwalb E, Barequet IS. Refractive results with secondary piggyback implantation to correct pseudophakic refractive errors. J Cataract Refract Surg. 2005 Nov;31(11):2101-3. — View Citation

Iwase T, Tanaka N. Elevated intraocular pressure in secondary piggyback intraocular lens implantation. J Cataract Refract Surg. 2005 Sep;31(9):1821-3. — View Citation

Kahraman G, Amon M. New supplementary intraocular lens for refractive enhancement in pseudophakic patients. J Cataract Refract Surg. 2010 Jul;36(7):1090-4. doi: 10.1016/j.jcrs.2009.12.045. — View Citation

Khan MI, Muhtaseb M. Performance of the Sulcoflex piggyback intraocular lens in pseudophakic patients. J Refract Surg. 2011 Sep;27(9):693-6. doi: 10.3928/1081597X-20110512-01. Epub 2011 May 20. — View Citation

Leaming DV. Practice styles and preferences of ASCRS members--2003 survey. J Cataract Refract Surg. 2004 Apr;30(4):892-900. — View Citation

Mamalis N, Brubaker J, Davis D, Espandar L, Werner L. Complications of foldable intraocular lenses requiring explantation or secondary intervention--2007 survey update. J Cataract Refract Surg. 2008 Sep;34(9):1584-91. doi: 10.1016/j.jcrs.2008.05.046. — View Citation

McIntyre JS, Werner L, Fuller SR, Kavoussi SC, Hill M, Mamalis N. Assessment of a single-piece hydrophilic acrylic IOL for piggyback sulcus fixation in pseudophakic cadaver eyes. J Cataract Refract Surg. 2012 Jan;38(1):155-62. doi: 10.1016/j.jcrs.2011.06.035. Epub 2011 Nov 4. — View Citation

Paul RA, Chew HF, Singal N, Rootman DS, Slomovic AR. Piggyback intraocular lens implantation to correct myopic pseudophakic refractive error after penetrating keratoplasty. J Cataract Refract Surg. 2004 Apr;30(4):821-5. — View Citation

Werner L, Apple DJ, Pandey SK, Solomon KD, Snyder ME, Brint SF, Gayton JL, Shugar JK, Trivedi RH, Izak AM. Analysis of elements of interlenticular opacification. Am J Ophthalmol. 2002 Mar;133(3):320-6. — View Citation

Werner L, Shugar JK, Apple DJ, Pandey SK, Escobar-Gomez M, Visessook N, Evans BB. Opacification of piggyback IOLs associated with an amorphous material attached to interlenticular surfaces. J Cataract Refract Surg. 2000 Nov;26(11):1612-9. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Refractive outcomes	refractive outcomes following surgical intervention	3 months	No
Primary	Best corrected and uncorrected visual acuity	Best corrected and uncorrected visual acuity following the IOL implantation	3 month	No
Secondary	Ocular complications	pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration	3 months	Yes